AU B96694Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14987666542989), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 30, 2025Completed

   Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.

   Z-1908-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED NA, K AND CL PATIENT RESULTS WERE ZERO (0) VALUE ON THE AU680 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF LABORATORY. THE EXACT NUMBER OF PATIENTS AFFECTED IS UNKNOWN. THE CUSTOMER DID NOT PROVIDE PATIENT DATA PRINTOUTS OR DEMOGRAPHICS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421481 ↗